- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04669054
Hospital Interns Psychological State During the COVID-19 (RESICOV)
Hospital Interns Psychological State During the COVID-19 Pandemic
The mental health of the French population in response to covid-19 pandemic is of concern.
Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Montpellier, Ranska, 34295
- University Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion criteria:
- Being a DES intern (Occitanie-Est)
- Being on internship as of November 1, 2020
Exclusion criteria:
- Refusal to participate
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Depressive Symptomatology (PHQ-9)
Aikaikkuna: at 5 months (6 months of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at 5 months (6 months of internship)
|
Depressive Symptomatology (PHQ-9)
Aikaikkuna: at inclusion (1 month of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at inclusion (1 month of internship)
|
Depressive Symptomatology (PHQ-9)
Aikaikkuna: at 2 months (3 months of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at 2 months (3 months of internship)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Sleep evaluation with the Insomnia Severity Index (ISI)
Aikaikkuna: at inclusion (1 month of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at inclusion (1 month of internship)
|
Sleep evaluation with the Insomnia Severity Index (ISI)
Aikaikkuna: at 2 months (3 months of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at 2 months (3 months of internship)
|
Sleep evaluation with the Insomnia Severity Index (ISI)
Aikaikkuna: at 5 months (6 months of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at 5 months (6 months of internship)
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Aikaikkuna: at inclusion (1 month of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at inclusion (1 month of internship)
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Aikaikkuna: at 2 months (3 months of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at 2 months (3 months of internship)
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Aikaikkuna: at 5 months (6 months of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at 5 months (6 months of internship)
|
Psychological pain assessed with visual analogue scale (VAS)
Aikaikkuna: at inclusion (1 month of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at inclusion (1 month of internship)
|
Psychological pain assessed with visual analogue scale (VAS)
Aikaikkuna: at 2 months (3 months of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 2 months (3 months of internship)
|
Psychological pain assessed with visual analogue scale (VAS)
Aikaikkuna: at 5 months (6 months of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 5 months (6 months of internship)
|
Physical pain assessed with visual analogue scale (VAS)
Aikaikkuna: at inclusion (1 month of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at inclusion (1 month of internship)
|
Physical pain assessed with visual analogue scale (VAS)
Aikaikkuna: at 2 months (3 months of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 2 months (3 months of internship)
|
Physical pain assessed with visual analogue scale (VAS)
Aikaikkuna: at 5 months (6 months of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 5 months (6 months of internship)
|
Suicidal ideation assessed with visual analogue scale (VAS)
Aikaikkuna: at inclusion (1 month of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at inclusion (1 month of internship)
|
Suicidal ideation assessed with visual analogue scale (VAS)
Aikaikkuna: at 2 months (3 months of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at 2 months (3 months of internship)
|
Suicidal ideation assessed with visual analogue scale (VAS)
Aikaikkuna: at 5 months (6 months of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at 5 months (6 months of internship)
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Aikaikkuna: at 2 months (3 months of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at 2 months (3 months of internship)
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Aikaikkuna: at 5 months (6 months of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at 5 months (6 months of internship)
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Aikaikkuna: at inclusion (1 month of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at inclusion (1 month of internship)
|
Stressful Event Impact (Horowitz scale)
Aikaikkuna: at inclusion (1 month of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at inclusion (1 month of internship)
|
Stressful Event Impact (Horowitz scale)
Aikaikkuna: at 2 months (3 months of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at 2 months (3 months of internship)
|
Stressful Event Impact (Horowitz scale)
Aikaikkuna: at 5 months (6 months of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at 5 months (6 months of internship)
|
Psychotropic drugs use
Aikaikkuna: at inclusion (1 month of internship)
|
assessement of the psychotropic drugs use increase
|
at inclusion (1 month of internship)
|
Psychotropic drugs use
Aikaikkuna: at 5 months (6 months of internship)
|
assessement of the psychotropic drugs use increase
|
at 5 months (6 months of internship)
|
Psychotropic drugs use
Aikaikkuna: at 2 months (3 months of internship)
|
assessement of the psychotropic drugs use increase
|
at 2 months (3 months of internship)
|
Tobacco consumption
Aikaikkuna: at 2 months (3 months of internship)
|
assessement of the tobacco consumption increase
|
at 2 months (3 months of internship)
|
Tobacco consumption
Aikaikkuna: at inclusion (1 month of internship)
|
assessement of the tobacco consumption increase
|
at inclusion (1 month of internship)
|
Tobacco consumption
Aikaikkuna: at 5 months (6 months of internship)
|
assessement of the tobacco consumption increase
|
at 5 months (6 months of internship)
|
Alcohol consumption
Aikaikkuna: at 2 months (3 months of internship)
|
assessement of the alcohol consumption increase
|
at 2 months (3 months of internship)
|
Alcohol consumption
Aikaikkuna: at inclusion (1 month of internship)
|
assessement of the alcohol consumption increase
|
at inclusion (1 month of internship)
|
Alcohol consumption
Aikaikkuna: at 5 months (6 months of internship)
|
assessement of the alcohol consumption increase
|
at 5 months (6 months of internship)
|
Illicit substances use
Aikaikkuna: at inclusion (1 month of internship)
|
assessement of the illicit substances use increase
|
at inclusion (1 month of internship)
|
Illicit substances use
Aikaikkuna: at 2 months (3 months of internship)
|
assessement of the illicit substances use increase
|
at 2 months (3 months of internship)
|
Illicit substances use
Aikaikkuna: at 5 months (6 months of internship)
|
assessement of the illicit substances use increase
|
at 5 months (6 months of internship)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Emilie Olie, MD PhD, University Hospital, Montpellier
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Mielenterveyshäiriöt
- Koronavirusinfektiot
- Coronaviridae-infektiot
- Nidovirales-infektiot
- RNA-virusinfektiot
- Virussairaudet
- Infektiot
- Hengitysteiden infektiot
- Hengityselinten sairaudet
- Keuhkokuume, virus
- Keuhkokuume
- Keuhkosairaudet
- Traumaan ja stressiin liittyvät häiriöt
- Stressihäiriöt, traumaattiset
- COVID-19
- Stressihäiriöt, posttraumaattiset
Muut tutkimustunnusnumerot
- RECHMPL20_0665
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .